MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Failure to Run on Battery (1466); Device Damaged Prior to Use (2284); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: bi71000450, serial/lot: (b)(4).Product id: bi71000450, serial/lot: (b)(4).A medtronic representative went to the site to perform a system check out and they found that the replacement ps1 was bat at install(bai), so another was sent.The bai ps1 had no output.With the original ps1 there was intermittent drops below 4.8 volts causing the generator to reset.The ps1 was replaced to resolve the issue.The voltage was adjusted to 5.15v.Both the bai ps1 and the original ps1 were returned for product analysis.The analyses are still in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that the system will not drive after being used and needed to be rebooted before it could drive.There was no patient involvement.Additional information received from a manufacturer representative reported that a replacement power supply(ps1) was bad at install.There was no output at initial power up.

Manufacturer Narrative

H3): product analysis was completed for the following: product id: bi71000450, serial/lot : (b)(6) product id: bi71000450, serial/lot : v18270378 a hardware analysis was initiated on bi71000450, serial/lot :(b)(6), serial/lot : (b)(6) to determine the probable cause of the issue.Analysis found that the "system will not drive."ps1 power supply was tested and the bench test failed.Output voltage drifted over the maximum limit spec.Electrical component failure.Fdm b01, fdr c02, fdc d02 applies to both product analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 11747416
• MDR Text Key: 248562452
• Report Number: 3004785967-2021-00551
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• Combination Product (y/n): N
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1